One critical function of the human (and animal) immune system is to assess whether a physical particle entering the body is a friend or foe. Occasionally for some people (and animals) and frequently or continuously for others, the immune system wrongly identifies an otherwise harmless particle as foe—acting as if the particle were a dangerous, infectious microorganism. The overtly harmless particle may be, e.g., a molecule of pollen, or dog dander, or cat saliva or any of a host of other proteins we know to be allergens, i.e., antigens that trigger an adverse immune system response in susceptible humans (and susceptible animals). Chromosomal characteristics seem to determine which members of any given population will “have allergies”; estimates of the United States population are that at least 20% and as many as 30% are atopic, i.e., they produce abnormal IgE and/or abnormal amounts of IgE, and thus develop hypersensitivity to allergens.
Asthma, rhinitis, eczema, urticaria, sinusitis and conjunctivitis all may be clinical signs of allergic reactions to environmental allergens. These clinical signs are associated with the immune system's release of histamine and other cytokines and their effects on the human body. This histamine-led, multiple cytokine cascade is triggered by the immune system's response to multiple, ubiquitous environmental allergens.
The currently recognized methods for dealing with allergies and allergy-based extrinsic asthma in humans (and animals) are: (i) avoidance of the source of the triggering allergen(s); (ii) pharmacotherapy; and (iii) immunotherapy. The first line of defense for allergic individuals is controlling their environment. Although initiating this control in public facilities can be difficult or even impossible, the allergic individual can largely protect his own home from allergy-producing antigens with the proper information. Allergists emphasize, through patient education, the need to remove or reduce from the residential environment allergen-producing sources, e.g., dogs, cats, dust mites, mold, cockroaches, indoor-flora and other sources. For physicians specializing in allergy, asthma and immunology, the control of the source of antigens in the home has historically taken precedence over treatment through immunotherapy or pharmacotherapy.
Pharmacotherapy includes a myriad of over-the-counter medications and prescription drugs designed to reduce the effects of the histamine response to allergens (antihistamines). These formulations relieve some clinical symptoms (in 40-50% of patients) but in no way “cure” the patient. Quite unlike immunotherapy, no permanent changes are evoked by pharmacotherapy-only brief respites from allergic symptoms.
When allergy symptoms persist despite encouragement of patients to avoid the source of allergens or to use medications, allergists suggest the introduction of immunotherapy in the form of allergy injections. Over time, the injections hyposensitize the patients. Ever increasing amounts of specific allergens are periodically introduced to the immune system. This eventually significantly reduces the scope and intensity of the cytokine response and thereby reduces the occurrence of allergic symptoms.
The “avoidance” method raises fairness, ethical and practical issues for an allergic patient and those with whom he lives. One could question whether a child's mild allergy to pets should cause, say, three other children and two adults to have to live without the salutary emotional benefits of living with two dogs and a cat that, themselves, have been “members of the family” for many years. Likewise one may question whether mold and pollen allergies for one member of an extended family should mean that twenty other members cannot have a large, cut, live Christmas tree for their annual two-day celebration at Grandmother's house. Likewise, an allergy to horse dander could mean that an annual three-day ride with friends will lose a key participant.
Equally problematic for the allergy sufferer are the costs and side effects of pharmacotherapy. Similarly, the cost and inconvenience of weekly or twice-weekly trips to a physician's office for immunotherapy injections can be overwhelming.
Given these shortcomings of the prevailing modalities of dealing with allergies, another modality-one that permits pets to remain in the home, that allows houseplants and Christmas trees to be natural-would be welcome and helpful to literally millions of allergy patients and those with whom they interact. Accordingly, there is a need in the art for such a modality.
Moreover, increasing evidence confirms that allergies can lead to more severe consequences. Thus, there is especially a need in the art for a modality that can mitigate the effects of allergens that are difficult, if not impossible to remove from the environment. For example, cockroach and rodent dander and urine can lead to pediatric asthma among inner city housing project residents. A modality for dealing with these difficult to eliminate allergens in the indoor environment would have lasting health benefits. The benefits are especially compelling in regard to a substantial disadvantaged population, one that cannot be reasonably expected to bear the cost of, and display the required discipline for, pharmacotherapy or immunotherapy.
With: (i) allergies as the number one cause of missed work; and (ii) asthma the number one cause both of missed school and childhood hospitalization; any effective additive modality in mitigation of the allergic response has an important role to play.